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CQV Validation Engineer

3 months ago

New Haven, United States Katalyst Healthcares and Life Sciences Full time
Responsibilities:
  • Authoring, editing, and executing technical commissioning, qualification and validation documentation for standard equipment/systems/ software, and processes as part of team as directed by the project leader
  • Running test scripts and documenting results
  • Adherence with project schedule for all assigned activities
  • Maintaining clear, detailed records qualification and validation
  • Documenting impact and risk assessments as part of a team
  • Completing user interface testing, software verification, and complete alarm testing on automated systems
  • Developing, reviewing, and executing testing documentation
  • Making recommendations for design or process modification based on test results when executing test scripts
  • General understanding of capital equipment implementation and process knowledge
  • Understanding validation documents, URS, IQ, OQ, PQ
Requirements:
  • Demonstrated experience in leading CQV activities specific to expertise in Facility and Utility qualification. Including qualification of Cleanrooms (including EMPQ), Warehouse, Compressed Gases, WFI, etc.
  • Proficiency in using PC and Microsoft Office tools.
  • Outgoing personality with strong ability to communicate effectively with peers in clear, concise terms.
  • GMP and Good Documentation Practice.
  • Intermediate skills with WORD. (authoring/editing large technical documents with styles, tables, TOCs, track changes)
  • Basic skills with EXCEL and PowerPoint.
  • Strong interpersonal skills and clear communication capabilities.
  • Experience with and tolerance for high levels of challenge and change.
  • Experience in GMP regulated environment.
  • Capable of working on assigned tasks without mentorship.